Testing Low-cost Learning Through Play (LTP) Plus Parenting Intervention for Depressed Fathers (LTP Plus Dads) A Cluster Randomized Controlled Trial (RCT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 357
- Locations
- 2
- Primary Endpoint
- Hamilton Depression Scale HAM-D 17 (Hamilton, 1960)
Study Overview
Brief Summary
The aim of the study is to evaluate the clinical and cost effectiveness of culturally adapted group parenting intervention delivered by non-specialists and community health workers for depressed fathers.
Detailed Description
Most research on the association between parental depression and child outcomes has focused mainly on mothers. However, studies suggest that the relationship between parental depression and child outcome is not necessarily limited to mothers.
The study has two phases quantitative and qualitative:
Purpose of this quantitative phase is to determine if the LTP plus programme delivered by non-specialists and community health workers reduces symptoms of paternal depression and improves child development compared to treatment as usual.
In the qualitative part of the study focus groups and in-depth digitally recorded interviews will be conducted with participants by trained research staff at two-time points both before and after the intervention. These focus groups and in-depth interviews will continue till the data saturation is achieved. In addition, Participants who refused to participate in the trial will be asked if they would be willing to be contacted by a researcher to discuss their reasons for not taking part. Moreover, in-depth digitally-recorded interviews with stakeholders (grandparents, therapists, health professionals, etc) will also be conducted by trained researchers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Researchers doing outcome assessment will be kept blind to the group allocations
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18 to 55 years old fathers
- •Having children aged between 0-30 months
- •Diagnosis of major depressive disorder using the Structure Clinical Interview for DSM-V,
- •Ability to complete a baseline assessment.
- •Given written informed consent
Exclusion Criteria
- •Any medical illness that will prevent them from participation in the clinical trial,
- •Current or past diagnosis of bipolar depression
- •Currently using antidepressants or receiving any kind of psychotherapy
- •Active suicidal ideation,
- •Any other severe physical or mental disorders
Arms & Interventions
LTP Plus
LTP Plus Participants will receive the intervention over 4 months Weekly sessions for 2 months and fortnightly for next two months by trained non-specialists/community health workers.
Intervention: LTP Plus (Behavioral)
Treatment As Usual (TAU)
Treatment as Usual (TAU) group will receive routine care and their follow up will be done at 4th and 6th month post randomization.
Outcomes
Primary Outcomes
Hamilton Depression Scale HAM-D 17 (Hamilton, 1960)
Time Frame: Changes from Baseline to 4th and 6th Month
The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. The HAM-D is a simple 17 item self-report questionnaire can also be administered by a trained research worker. The translated version of the scale has been used in previous studies in Pakistan (Husain et al., 2017). It takes about 10 to 15 minutes to administer this scale. A score of 0-7 indicates normal, 8-13 mild depression, 14-18 moderate depression, 19-22 severe depression and \> 22 severe depression
Secondary Outcomes
- Brief Disability Questionnaire BDQ:(Von Korff, Ustun, Ormel, Kaplan, & Simon, 1996)(Changes from Baseline to 4th and 6th Month)
- Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, & Williams, 2003)(Changes from Baseline to 4th and 6th Month)
- Parenting Scale (Arnold, O'leary, Wolff, & Acker, 1993)(Changes from Baseline to 4th and 6th Month)
- Generalized Anxiety Disorder (GAD) 7 (Spitzer, Kroenke, Williams, & Löwe, 2006):(Changes from Baseline to 4th and 6th Month)
- Rosenberg's Self-Esteem Scale (Rosenberg, 1995)(Changes from Baseline to 4th and 6th Month)
- Client Satisfaction Questionnaire (CSQ) (Attkisson & Greenfield, 1995)(After completion of the intervention at 4th month only)
- Euro-Qol-5 Dimensions (EQ-5D) ( Brooks R. EuroQol,.1996)(Changes from Baseline to 4th and 6th Month)
- Hurt, Insulted, Threatened with Harm and Screamed (HITS) (Sherin, Sinacore, Li, Zitter, & Shakil, 1998):(Changes from Baseline to 4th and 6th Month)
- Dyadic Adjustment Scale (DAS):(Spanier, 1976)(Changes from Baseline to 4th and 6th Month)
- Knowledge of Expectation and Child Development(Changes from Baseline to 4th and 6th Month)
- OSLO 3 (Nosikov & Gudex, 2003)(Changes from Baseline to 4th and 6th Month)
- Parenting Stress Index - Short Form (Abidin, 1995)(Changes from Baseline to 4th and 6th Month)
- Eyberg Child Behaviour Inventory (ECBI) (Eyberg, Boggs, & Reynolds, 1980)(Changes from Baseline to 4th and 6th Month)
- Manchester Assessment of Caregiver-Infant Interaction (MACI)(Changes from Baseline to 6th Month)
- Anthropometric measures (Weight)(Changes from Baseline, to 4th and 6th Month)
- Anthropometric measures (Height)(Changes from Baseline, to 4th and 6th Month)
- Anthropometric measures (Head Circumference)(Changes from Baseline, to 4th and 6th Month)
- Anthropometric measures (Arm Circumference)(Changes from Baseline, to 4th and 6th Month)
- Ages and Stages Social-Emotional Questionnaire(Squires et al., 2009)(Changes from Baseline to 4th and 6th Month)
- Infant development: Ages and Stages Questionnaire (Squires, Bricker, & Twombly, 2009)(Changes from Baseline to 4th and 6th Month)
- Bayley Scales of Infant Development (BSID-V3) (Bayley, Nancy (2006(Changes from Baseline to 6th Month)